Lainie Friedman Ross
- Published in print:
- 2006
- Published Online:
- May 2006
- ISBN:
- 9780199273287
- eISBN:
- 9780191603655
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/0199273286.003.0008
- Subject:
- Philosophy, Moral Philosophy
Institutional review board (IRB) review is required for all federally funded research involving human subjects regulated by the Food and Drug Administration, or performed at an institution that ...
More
Institutional review board (IRB) review is required for all federally funded research involving human subjects regulated by the Food and Drug Administration, or performed at an institution that accepts federal funds. The requirement to document IRB review and the procurement of informed consent (IC) in published research reports is more recent. This chapter examines to what extent research published in three peer-reviewed pediatric journals documented IRB approval and IC, and to what extent the researchers who failed to document IRB and IC stated that they had obtained appropriate IRB review and consent from subjects. It was observed that a small but significant number of pediatric research protocols failed to obtain IRB approval or a waiver.Less
Institutional review board (IRB) review is required for all federally funded research involving human subjects regulated by the Food and Drug Administration, or performed at an institution that accepts federal funds. The requirement to document IRB review and the procurement of informed consent (IC) in published research reports is more recent. This chapter examines to what extent research published in three peer-reviewed pediatric journals documented IRB approval and IC, and to what extent the researchers who failed to document IRB and IC stated that they had obtained appropriate IRB review and consent from subjects. It was observed that a small but significant number of pediatric research protocols failed to obtain IRB approval or a waiver.
Robert J. Levine
- Published in print:
- 2009
- Published Online:
- September 2009
- ISBN:
- 9780195322934
- eISBN:
- 9780199864416
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195322934.003.0012
- Subject:
- Public Health and Epidemiology, Public Health, Epidemiology
This chapter describes the committees responsible for reviewing proposals to conduct research involving humans as subjects to determine whether they include adequate safeguards of the rights and ...
More
This chapter describes the committees responsible for reviewing proposals to conduct research involving humans as subjects to determine whether they include adequate safeguards of the rights and welfare of the research subjects. These committees, generally called institutional review boards (IRBs), now exist in many locales in most countries. National regulations in an increasing number of countries and the leading international codes of research ethics establish the requirement that research involving humans as subjects, with few exceptions, may not be carried out without review and approval of these committees; hence their importance to epidemiologists. The history, composition, organizational settings, purposes of these committees, and major themes in contemporary controversies about them are discussed.Less
This chapter describes the committees responsible for reviewing proposals to conduct research involving humans as subjects to determine whether they include adequate safeguards of the rights and welfare of the research subjects. These committees, generally called institutional review boards (IRBs), now exist in many locales in most countries. National regulations in an increasing number of countries and the leading international codes of research ethics establish the requirement that research involving humans as subjects, with few exceptions, may not be carried out without review and approval of these committees; hence their importance to epidemiologists. The history, composition, organizational settings, purposes of these committees, and major themes in contemporary controversies about them are discussed.
David B. Resnik
- Published in print:
- 2009
- Published Online:
- January 2009
- ISBN:
- 9780195375893
- eISBN:
- 9780199866632
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195375893.003.0007
- Subject:
- Philosophy, Moral Philosophy
This chapter discusses some problems with the current U.S. system for protecting human research subjects. These problems indicate that in some ways the regulations provide too much oversight, in ...
More
This chapter discusses some problems with the current U.S. system for protecting human research subjects. These problems indicate that in some ways the regulations provide too much oversight, in others too little. Examples of too much oversight include excessive paperwork, the review of low‐risk research, and an overly broad definition of research; examples of too little include inconsistencies and loopholes in the regulations, lack of compensation for injuries, inconsistent adverse event reporting, and lack of broad research review. Federal regulations and guidelines for research should be revised so that there is more emphasis on protection of human subjects and less emphasis on bureaucratic, administrative, and technical/legal issues. Although the current system has some problems, it has operated very well for more than three decades. In many ways, the institutional review board (IRB) system represents a judicious compromise between government oversight of human research and scientific autonomy. While there is no need to overhaul the system, changes should be made to improve the quality, scope, effectiveness, and fairness of research review and oversight.Less
This chapter discusses some problems with the current U.S. system for protecting human research subjects. These problems indicate that in some ways the regulations provide too much oversight, in others too little. Examples of too much oversight include excessive paperwork, the review of low‐risk research, and an overly broad definition of research; examples of too little include inconsistencies and loopholes in the regulations, lack of compensation for injuries, inconsistent adverse event reporting, and lack of broad research review. Federal regulations and guidelines for research should be revised so that there is more emphasis on protection of human subjects and less emphasis on bureaucratic, administrative, and technical/legal issues. Although the current system has some problems, it has operated very well for more than three decades. In many ways, the institutional review board (IRB) system represents a judicious compromise between government oversight of human research and scientific autonomy. While there is no need to overhaul the system, changes should be made to improve the quality, scope, effectiveness, and fairness of research review and oversight.
Dean O. Smith
- Published in print:
- 2011
- Published Online:
- September 2011
- ISBN:
- 9780199793259
- eISBN:
- 9780199896813
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780199793259.003.0012
- Subject:
- Economics and Finance, Economic Systems
In most developed countries, current standards for the responsible conduct of research with human subjects derive from the Nuremberg Code. It has been amplified in the Belmont Report, which is the ...
More
In most developed countries, current standards for the responsible conduct of research with human subjects derive from the Nuremberg Code. It has been amplified in the Belmont Report, which is the basis of federal guidelines (known as the common rule) for research using human subjects. Each institution that conducts research on human subjects must submit an assurance that guarantees compliance with federal policy. No research project involving human subjects may proceed without an approved assurance on file. Federal policy also requires the establishment of an institutional review board (IRB) to review all proposed and ongoing research projects involving human subjects. The IRB has the authority to approve human subject research protocols. Federal policy dictates IRB membership criteria. Some universities use independent, for-profit IRBs to review protocols. Guidelines for expedited and exempt protocol reviews are described. The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) accredits institutional human research protection programs, including IRB activities. The chapter concludes with an analysis of current federal regulations on research using human embryonic stem cells.Less
In most developed countries, current standards for the responsible conduct of research with human subjects derive from the Nuremberg Code. It has been amplified in the Belmont Report, which is the basis of federal guidelines (known as the common rule) for research using human subjects. Each institution that conducts research on human subjects must submit an assurance that guarantees compliance with federal policy. No research project involving human subjects may proceed without an approved assurance on file. Federal policy also requires the establishment of an institutional review board (IRB) to review all proposed and ongoing research projects involving human subjects. The IRB has the authority to approve human subject research protocols. Federal policy dictates IRB membership criteria. Some universities use independent, for-profit IRBs to review protocols. Guidelines for expedited and exempt protocol reviews are described. The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) accredits institutional human research protection programs, including IRB activities. The chapter concludes with an analysis of current federal regulations on research using human embryonic stem cells.
Steven S. Coughlin, Tom L. Beauchamp, and Douglas L. Weed (eds)
- Published in print:
- 2009
- Published Online:
- September 2009
- ISBN:
- 9780195322934
- eISBN:
- 9780199864416
- Item type:
- book
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195322934.001.0001
- Subject:
- Public Health and Epidemiology, Public Health, Epidemiology
In the ten years since the first edition of this book was published, there have been many important ethical developments in epidemiology and related fields in public health and medicine. These ...
More
In the ten years since the first edition of this book was published, there have been many important ethical developments in epidemiology and related fields in public health and medicine. These developments include implementation of the HIPAA privacy rules, the completion of the American College of Epidemiology (ACE) ethics guidelines and ACE policy statements on sharing data from epidemiologic studies, and the drafting of a public health code of ethics. This revised edition of the text includes selected chapters from the first edition, which have been updated and revised, along with several new chapters on issues concerning the ethics of public health practice, international health research, and genetic epidemiology. The chapters are organized topically and divided into four parts. The first part is titled “Foundations” because the chapters introduce basic and recurring concepts and principles. The subsequent parts deal with “Informed Consent, Privacy, and Confidentiality,” “Balancing Risks and Benefits,” and the “Regulatory Context and Professional Education.” The latter subject includes discussion of the institutional review board (IRB) system and issues surrounding scientific misconduct in epidemiologic research. The objective of this work foster greater awareness of situations that require moral reflection, judgment, or decision, while pointing to ways in which justified moral conclusions can be reached.Less
In the ten years since the first edition of this book was published, there have been many important ethical developments in epidemiology and related fields in public health and medicine. These developments include implementation of the HIPAA privacy rules, the completion of the American College of Epidemiology (ACE) ethics guidelines and ACE policy statements on sharing data from epidemiologic studies, and the drafting of a public health code of ethics. This revised edition of the text includes selected chapters from the first edition, which have been updated and revised, along with several new chapters on issues concerning the ethics of public health practice, international health research, and genetic epidemiology. The chapters are organized topically and divided into four parts. The first part is titled “Foundations” because the chapters introduce basic and recurring concepts and principles. The subsequent parts deal with “Informed Consent, Privacy, and Confidentiality,” “Balancing Risks and Benefits,” and the “Regulatory Context and Professional Education.” The latter subject includes discussion of the institutional review board (IRB) system and issues surrounding scientific misconduct in epidemiologic research. The objective of this work foster greater awareness of situations that require moral reflection, judgment, or decision, while pointing to ways in which justified moral conclusions can be reached.
Ann Nichols-Casebolt
- Published in print:
- 2012
- Published Online:
- May 2012
- ISBN:
- 9780195378108
- eISBN:
- 9780199932634
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195378108.003.0005
- Subject:
- Social Work, Research and Evaluation
The protection of human subjects in research, the regulations that govern the use of human subjects, and the role of the IRB in carrying out those regulations have been the subject of much discussion ...
More
The protection of human subjects in research, the regulations that govern the use of human subjects, and the role of the IRB in carrying out those regulations have been the subject of much discussion among social scientists. This chapter presents information on the ethical and practical considerations in using human subjects in social science research. It examines the principles underlying the current regulatory system, what they mean for social behavioral research, and how those conducting such research might best work within the Institutional Review Board (IRB) system. It will pay particular attention to conducting research with vulnerable populations, and protection issues related to community-engaged studies. The chapter also presents information about the implications of the Health Insurance Portability and Accountability (HIPPA) Act for social science research.Less
The protection of human subjects in research, the regulations that govern the use of human subjects, and the role of the IRB in carrying out those regulations have been the subject of much discussion among social scientists. This chapter presents information on the ethical and practical considerations in using human subjects in social science research. It examines the principles underlying the current regulatory system, what they mean for social behavioral research, and how those conducting such research might best work within the Institutional Review Board (IRB) system. It will pay particular attention to conducting research with vulnerable populations, and protection issues related to community-engaged studies. The chapter also presents information about the implications of the Health Insurance Portability and Accountability (HIPPA) Act for social science research.
Laura Stark
- Published in print:
- 2012
- Published Online:
- September 2013
- ISBN:
- 9780226770864
- eISBN:
- 9780226770888
- Item type:
- book
- Publisher:
- University of Chicago Press
- DOI:
- 10.7208/chicago/9780226770888.001.0001
- Subject:
- History, History of Science, Technology, and Medicine
Although the subject of federally mandated institutional review boards (IRBs) has been extensively debated, we do not know much about what takes place when they convene. The story of how IRBs work ...
More
Although the subject of federally mandated institutional review boards (IRBs) has been extensively debated, we do not know much about what takes place when they convene. The story of how IRBs work today is a story about their past as well as their present, and this book melds firsthand observations of IRB meetings with the history of how rules for the treatment of human subjects were formalized in the United States in the decades after World War II. Drawing on extensive archival sources, it reconstructs the daily lives of scientists, lawyers, administrators, and research subjects working—and “warring”—on the campus of the National Institutes of Health, where they first wrote the rules for the treatment of human subjects. The author argues that the model of group deliberation which gradually crystallized during this period reflected contemporary legal and medical conceptions of what it meant to be human, what political rights human subjects deserved, and which stakeholders were best suited to decide. She then explains how the historical contingencies that shaped rules for the treatment of human subjects in the postwar era guide decision making today—within hospitals, universities, health departments, and other institutions in the United States and across the globe.Less
Although the subject of federally mandated institutional review boards (IRBs) has been extensively debated, we do not know much about what takes place when they convene. The story of how IRBs work today is a story about their past as well as their present, and this book melds firsthand observations of IRB meetings with the history of how rules for the treatment of human subjects were formalized in the United States in the decades after World War II. Drawing on extensive archival sources, it reconstructs the daily lives of scientists, lawyers, administrators, and research subjects working—and “warring”—on the campus of the National Institutes of Health, where they first wrote the rules for the treatment of human subjects. The author argues that the model of group deliberation which gradually crystallized during this period reflected contemporary legal and medical conceptions of what it meant to be human, what political rights human subjects deserved, and which stakeholders were best suited to decide. She then explains how the historical contingencies that shaped rules for the treatment of human subjects in the postwar era guide decision making today—within hospitals, universities, health departments, and other institutions in the United States and across the globe.
Curtis L. Meinert
- Published in print:
- 2011
- Published Online:
- September 2011
- ISBN:
- 9780199742967
- eISBN:
- 9780199897278
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780199742967.003.0009
- Subject:
- Public Health and Epidemiology, Epidemiology, Public Health
This chapter begins with a chronology of requirements/guidelines pursuant to research on human beings, with emphasis on clinical trials. It then describes institutional review boards (IRBs) and IRB ...
More
This chapter begins with a chronology of requirements/guidelines pursuant to research on human beings, with emphasis on clinical trials. It then describes institutional review boards (IRBs) and IRB membership requirements.Less
This chapter begins with a chronology of requirements/guidelines pursuant to research on human beings, with emphasis on clinical trials. It then describes institutional review boards (IRBs) and IRB membership requirements.
Diana C. Mutz
- Published in print:
- 2011
- Published Online:
- October 2017
- ISBN:
- 9780691144511
- eISBN:
- 9781400840489
- Item type:
- chapter
- Publisher:
- Princeton University Press
- DOI:
- 10.23943/princeton/9780691144511.003.0006
- Subject:
- Sociology, Social Research and Statistics
This chapter aims to eliminate the need for others to learn by trial and error. The practical issues addressed here range from the process of explaining a population-based experiment to the ...
More
This chapter aims to eliminate the need for others to learn by trial and error. The practical issues addressed here range from the process of explaining a population-based experiment to the Institutional Review Board (IRB), to the issue of maximizing the effectiveness of a treatment in a population-based experiment. Different disciplines had different problems adapting to the idea of a population-based experiment, and the chapter uses various war stories to illustrate the kinds of problems most likely to plague users from different disciplines. The challenge of producing effective treatments involves simultaneously increasing the extent to which the independent variable is varied and reducing measurement error. Consideration of ethics and human subjects comes into play because there are important limits on what investigators can do by way of manipulation in the context of surveys.Less
This chapter aims to eliminate the need for others to learn by trial and error. The practical issues addressed here range from the process of explaining a population-based experiment to the Institutional Review Board (IRB), to the issue of maximizing the effectiveness of a treatment in a population-based experiment. Different disciplines had different problems adapting to the idea of a population-based experiment, and the chapter uses various war stories to illustrate the kinds of problems most likely to plague users from different disciplines. The challenge of producing effective treatments involves simultaneously increasing the extent to which the independent variable is varied and reducing measurement error. Consideration of ethics and human subjects comes into play because there are important limits on what investigators can do by way of manipulation in the context of surveys.
Greg Koski
- Published in print:
- 2006
- Published Online:
- September 2009
- ISBN:
- 9780195176360
- eISBN:
- 9780199865598
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195176360.003.08
- Subject:
- Public Health and Epidemiology, Public Health, Epidemiology
Medical research, and specifically clinical trial research on human subjects, is necessary to make advances in medicine. Such research depends on high levels of trust between the subjects and the ...
More
Medical research, and specifically clinical trial research on human subjects, is necessary to make advances in medicine. Such research depends on high levels of trust between the subjects and the physician scientists conducting the trials. This chapter addresses the erosion of public trust in health research, its causes and consequences, and some solutions. Abuses of the past have left a broad legacy of mistrust. Government regulation attempted to impose better procedures to ensure good medical ethics. Institutional Review Boards were formed to monitor federally funded research. However, patient mistrust and conflicts of interest by researchers remain concerns in the field. The chapter recommends moving from a culture of compliance to a culture of conscience, in which people act responsibly because it is the right thing to do. In addition, it discusses the importance of providing incentives for good performance.Less
Medical research, and specifically clinical trial research on human subjects, is necessary to make advances in medicine. Such research depends on high levels of trust between the subjects and the physician scientists conducting the trials. This chapter addresses the erosion of public trust in health research, its causes and consequences, and some solutions. Abuses of the past have left a broad legacy of mistrust. Government regulation attempted to impose better procedures to ensure good medical ethics. Institutional Review Boards were formed to monitor federally funded research. However, patient mistrust and conflicts of interest by researchers remain concerns in the field. The chapter recommends moving from a culture of compliance to a culture of conscience, in which people act responsibly because it is the right thing to do. In addition, it discusses the importance of providing incentives for good performance.
Ruth G. McRoy, Jerry P. Flanzer, and Joan Levy Zlotnik
- Published in print:
- 2012
- Published Online:
- May 2012
- ISBN:
- 9780195399646
- eISBN:
- 9780199932757
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195399646.003.0005
- Subject:
- Social Work, Research and Evaluation
This chapter explains the role of research administrators in providing leadership and expertise in supporting faculty grant applicants by addressing all the administrative aspects of the pre and post ...
More
This chapter explains the role of research administrators in providing leadership and expertise in supporting faculty grant applicants by addressing all the administrative aspects of the pre and post award activities. These activities may include supporting the investigator in navigating the complex system of university sponsor, state and federal regulations. Details are provided about the role of the office of sponsored research within a university, developing budget justifications, policies and practices around indirect rates, human subjects, effort certification as well as preparation of expenditure reports.Less
This chapter explains the role of research administrators in providing leadership and expertise in supporting faculty grant applicants by addressing all the administrative aspects of the pre and post award activities. These activities may include supporting the investigator in navigating the complex system of university sponsor, state and federal regulations. Details are provided about the role of the office of sponsored research within a university, developing budget justifications, policies and practices around indirect rates, human subjects, effort certification as well as preparation of expenditure reports.
Cindy Dell Clark
- Published in print:
- 2010
- Published Online:
- January 2011
- ISBN:
- 9780195376593
- eISBN:
- 9780199865437
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195376593.003.0002
- Subject:
- Psychology, Developmental Psychology, Clinical Child Psychology / School Psychology
Child-centered inquiry has been influenced by a variety of sources. A central notion is that children should be studied as social actors in their own right. This idea was especially propelled by the ...
More
Child-centered inquiry has been influenced by a variety of sources. A central notion is that children should be studied as social actors in their own right. This idea was especially propelled by the United Nations Convention on the Rights of the Child held in 1989, giving way to methodological innovation around the globe aimed at exploring children’s concerns and salient issues. A core dilemma of child-centered methods concerns whether investigators should take on completely child-like roles during research (“least-adult”), or alternatively act out a more mature stance in the course of seeking connection with children. This dilemma ties to common calls for reflexivity by the researcher and active participation by the young. Ironically, while children sometimes participate as active co-researchers in child-centered inquiry, under current U.S. Institutional Review Board (IRB) practices, they are given only secondary status in consenting to a study.Less
Child-centered inquiry has been influenced by a variety of sources. A central notion is that children should be studied as social actors in their own right. This idea was especially propelled by the United Nations Convention on the Rights of the Child held in 1989, giving way to methodological innovation around the globe aimed at exploring children’s concerns and salient issues. A core dilemma of child-centered methods concerns whether investigators should take on completely child-like roles during research (“least-adult”), or alternatively act out a more mature stance in the course of seeking connection with children. This dilemma ties to common calls for reflexivity by the researcher and active participation by the young. Ironically, while children sometimes participate as active co-researchers in child-centered inquiry, under current U.S. Institutional Review Board (IRB) practices, they are given only secondary status in consenting to a study.
Laura Stark
- Published in print:
- 2012
- Published Online:
- September 2013
- ISBN:
- 9780226770864
- eISBN:
- 9780226770888
- Item type:
- chapter
- Publisher:
- University of Chicago Press
- DOI:
- 10.7208/chicago/9780226770888.003.0003
- Subject:
- History, History of Science, Technology, and Medicine
This chapter examines the importance of local precedents in the decision making process of institutional review boards (IRBs) based on a survey of the chairman of IRBs in major research universities ...
More
This chapter examines the importance of local precedents in the decision making process of institutional review boards (IRBs) based on a survey of the chairman of IRBs in major research universities in the United States. It explains that IRB members identify new problems somewhat idiosyncratically and they develop remedies for these problems by drawing on warrants of experts. It suggests that the way the IRB works resonates with what it called analogical reasoning which was developed in Anglo-American law and medicine during the late nineteenth century.Less
This chapter examines the importance of local precedents in the decision making process of institutional review boards (IRBs) based on a survey of the chairman of IRBs in major research universities in the United States. It explains that IRB members identify new problems somewhat idiosyncratically and they develop remedies for these problems by drawing on warrants of experts. It suggests that the way the IRB works resonates with what it called analogical reasoning which was developed in Anglo-American law and medicine during the late nineteenth century.
Henry S. Richardson
- Published in print:
- 2012
- Published Online:
- January 2013
- ISBN:
- 9780195388930
- eISBN:
- 9780199979196
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195388930.003.0008
- Subject:
- Philosophy, Moral Philosophy
Summing up the book, this chapter reviews the argument, notes the novelty of the partial-entrustment model and, looking forward, sets out practical steps that can be recommended even without ...
More
Summing up the book, this chapter reviews the argument, notes the novelty of the partial-entrustment model and, looking forward, sets out practical steps that can be recommended even without committing to that approach. The partial-entrustment approach is shown to be an important addition to the bioethical principles set out by Beauchamp & Childress (2009) and Emanuel et al. (2004) and to evade worries about paternalism raised by Wertheimer & Miller (2007). Further, the idea of moral entanglements on which it rests is of interest, more broadly, to moral philosophers. Regarding practical steps that need to be taken, the “four Ps” of a 2008 consensus paper by participants in a Georgetown ancillary-care workshop are reiterated and reinforced, along with their framework of three key questions for Institutional Review Boards and Research Ethics Committees.Less
Summing up the book, this chapter reviews the argument, notes the novelty of the partial-entrustment model and, looking forward, sets out practical steps that can be recommended even without committing to that approach. The partial-entrustment approach is shown to be an important addition to the bioethical principles set out by Beauchamp & Childress (2009) and Emanuel et al. (2004) and to evade worries about paternalism raised by Wertheimer & Miller (2007). Further, the idea of moral entanglements on which it rests is of interest, more broadly, to moral philosophers. Regarding practical steps that need to be taken, the “four Ps” of a 2008 consensus paper by participants in a Georgetown ancillary-care workshop are reiterated and reinforced, along with their framework of three key questions for Institutional Review Boards and Research Ethics Committees.
Julianne S. Oktay
- Published in print:
- 2012
- Published Online:
- May 2012
- ISBN:
- 9780199753697
- eISBN:
- 9780199932627
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780199753697.003.0006
- Subject:
- Social Work, Research and Evaluation
This chapter addresses how grounded theory is affected by a variety of recent developments in social work research. These include a discussion of why it is sometimes difficult to conduct a grounded ...
More
This chapter addresses how grounded theory is affected by a variety of recent developments in social work research. These include a discussion of why it is sometimes difficult to conduct a grounded theory study today, and what to do when you want to develop theory but it is impractical to apply the grounded theory method. The chapter also considers ethical and institutional review board issues in grounded theory research. Attention is given to the practical considerations of publishing formats for grounded theory studies, with illustrations from exemplar grounded theory studies. It also discusses the use of computer software programs in grounded theory analysis. It considers the use of grounded theory in mixed method research. Finally, it discusses “formal grounded theory,” the grounded theory model for synthesizing qualitative studies. Exercises designed to help readers apply the material in the chapter to their own research are provided.Less
This chapter addresses how grounded theory is affected by a variety of recent developments in social work research. These include a discussion of why it is sometimes difficult to conduct a grounded theory study today, and what to do when you want to develop theory but it is impractical to apply the grounded theory method. The chapter also considers ethical and institutional review board issues in grounded theory research. Attention is given to the practical considerations of publishing formats for grounded theory studies, with illustrations from exemplar grounded theory studies. It also discusses the use of computer software programs in grounded theory analysis. It considers the use of grounded theory in mixed method research. Finally, it discusses “formal grounded theory,” the grounded theory model for synthesizing qualitative studies. Exercises designed to help readers apply the material in the chapter to their own research are provided.
Laura Stark
- Published in print:
- 2012
- Published Online:
- September 2013
- ISBN:
- 9780226770864
- eISBN:
- 9780226770888
- Item type:
- chapter
- Publisher:
- University of Chicago Press
- DOI:
- 10.7208/chicago/9780226770888.003.0001
- Subject:
- History, History of Science, Technology, and Medicine
This introductory chapter discusses the theme of this volume which is about the role of institutional review boards (IRBs) in designing the U.S. government rules for the treatment of human subjects ...
More
This introductory chapter discusses the theme of this volume which is about the role of institutional review boards (IRBs) in designing the U.S. government rules for the treatment of human subjects in research after World War II and the present-day consequences of their choice to adopt review procedures rather than ethics principles. This volume is divided into two main sections. The first section offers an analysis of actual IRB meetings and the second explains how the moral authority to decide how to treat research participants was relocated from professions to the state and reinvested in procedures rather than ethics principles.Less
This introductory chapter discusses the theme of this volume which is about the role of institutional review boards (IRBs) in designing the U.S. government rules for the treatment of human subjects in research after World War II and the present-day consequences of their choice to adopt review procedures rather than ethics principles. This volume is divided into two main sections. The first section offers an analysis of actual IRB meetings and the second explains how the moral authority to decide how to treat research participants was relocated from professions to the state and reinvested in procedures rather than ethics principles.
Alex John London
- Published in print:
- 2022
- Published Online:
- December 2021
- ISBN:
- 9780197534830
- eISBN:
- 9780197534861
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/oso/9780197534830.003.0007
- Subject:
- Philosophy, Moral Philosophy
This chapter argues that prospective review of research before bodies of diverse representation should not be understood as a paternalistic interference in the private interactions between ...
More
This chapter argues that prospective review of research before bodies of diverse representation should not be understood as a paternalistic interference in the private interactions between researchers and participants. Instead, it is a mechanism for resolving a set of coordination problems that threaten the integrity of research. Its proper role is to provide credible social assurance that the research enterprise constitutes a voluntary scheme of cooperation through which diverse stakeholders can contribute to the common good without being subject to the arbitrary exercise of social authority including antipathy, abuse, coercion, domination, exploitation, or other forms of harmful, unfair, or disrespectful treatment. The limitations of prospective review are discussed, including the need for mechanisms that better address incentives for a wider range of stakeholders whose decisions shape the research agenda.Less
This chapter argues that prospective review of research before bodies of diverse representation should not be understood as a paternalistic interference in the private interactions between researchers and participants. Instead, it is a mechanism for resolving a set of coordination problems that threaten the integrity of research. Its proper role is to provide credible social assurance that the research enterprise constitutes a voluntary scheme of cooperation through which diverse stakeholders can contribute to the common good without being subject to the arbitrary exercise of social authority including antipathy, abuse, coercion, domination, exploitation, or other forms of harmful, unfair, or disrespectful treatment. The limitations of prospective review are discussed, including the need for mechanisms that better address incentives for a wider range of stakeholders whose decisions shape the research agenda.
Philip Hamburger
- Published in print:
- 2015
- Published Online:
- November 2015
- ISBN:
- 9780231168809
- eISBN:
- 9780231538794
- Item type:
- chapter
- Publisher:
- Columbia University Press
- DOI:
- 10.7312/columbia/9780231168809.003.0009
- Subject:
- Philosophy, Moral Philosophy
This chapter examines conflicting norms in the government's licensing of speech and the press on “human-subjects research” through institutional review boards (IRBs). It begins by discussing ...
More
This chapter examines conflicting norms in the government's licensing of speech and the press on “human-subjects research” through institutional review boards (IRBs). It begins by discussing licensing and why the prohibition of it is so fundamental and prroceeds by providing an overview of the structure of institutional review board licensing. It then highlights the unconstitutionality of IRB laws, arguing that the use of IRBs violates the principles of academic freedom. It asserts that licensing of speech or the press was a method of controlling the press employed by the Inquisition and the Star Chamber, and the First Amendment unequivocally barred it. Particularly in medical research and its publication, the suppression evidently causes several thousands of deaths each year. The chapter considers the IRB censorship to be the most widespread and systematic assault on the freedom of speech and the press in U.S. history.Less
This chapter examines conflicting norms in the government's licensing of speech and the press on “human-subjects research” through institutional review boards (IRBs). It begins by discussing licensing and why the prohibition of it is so fundamental and prroceeds by providing an overview of the structure of institutional review board licensing. It then highlights the unconstitutionality of IRB laws, arguing that the use of IRBs violates the principles of academic freedom. It asserts that licensing of speech or the press was a method of controlling the press employed by the Inquisition and the Star Chamber, and the First Amendment unequivocally barred it. Particularly in medical research and its publication, the suppression evidently causes several thousands of deaths each year. The chapter considers the IRB censorship to be the most widespread and systematic assault on the freedom of speech and the press in U.S. history.
Phil Brown, Rachel Morello-Frosch, Julia Green Brody, Rebecca Gasior Altman, Ruthann A. Rudel, Laura Senier, Carla Pérez, and Ruth Simpson
- Published in print:
- 2011
- Published Online:
- January 2017
- ISBN:
- 9780520270206
- eISBN:
- 9780520950429
- Item type:
- chapter
- Publisher:
- University of California Press
- DOI:
- 10.1525/california/9780520270206.003.0014
- Subject:
- Public Health and Epidemiology, Public Health
This chapter outlines the challenges of obtaining institutional review board (IRB) coverage for community-based participatory research (CBPR) projects. Community-based participatory research focuses ...
More
This chapter outlines the challenges of obtaining institutional review board (IRB) coverage for community-based participatory research (CBPR) projects. Community-based participatory research focuses on problems that affect whole communities and thus is different from most biomedical research, which takes the individual as its primary subject. In CBPR projects, researchers work closely with community members and community-based organizations to develop appropriate research agendas, conduct analyses, and disseminate results and information. In general, IRBs are unfamiliar with this approach to research, reluctant to take responsibility for the actions of community partner organizations, and resistant to interaction between researchers and participants. Their hesitation causes significant delays and may prevent effective research and dissemination of results. The chapter then suggests concrete ways in which IRBs and funders can develop clear review guidelines that respect the unique qualities of CBPR.Less
This chapter outlines the challenges of obtaining institutional review board (IRB) coverage for community-based participatory research (CBPR) projects. Community-based participatory research focuses on problems that affect whole communities and thus is different from most biomedical research, which takes the individual as its primary subject. In CBPR projects, researchers work closely with community members and community-based organizations to develop appropriate research agendas, conduct analyses, and disseminate results and information. In general, IRBs are unfamiliar with this approach to research, reluctant to take responsibility for the actions of community partner organizations, and resistant to interaction between researchers and participants. Their hesitation causes significant delays and may prevent effective research and dissemination of results. The chapter then suggests concrete ways in which IRBs and funders can develop clear review guidelines that respect the unique qualities of CBPR.
I. Glenn Cohen and Holly Fernandez Lynch (eds)
- Published in print:
- 2014
- Published Online:
- January 2015
- ISBN:
- 9780262027465
- eISBN:
- 9780262320825
- Item type:
- book
- Publisher:
- The MIT Press
- DOI:
- 10.7551/mitpress/9780262027465.001.0001
- Subject:
- Biology, Bioethics
The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation, revealed at the Nuremburg trials, and the Tuskegee ...
More
The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation, revealed at the Nuremburg trials, and the Tuskegee syphilis study, conducted by U.S. government researchers from 1932 to 1972. This framework, combining elements of paternalism with efforts to preserve individual autonomy, has remained fundamentally unchanged for decades. Yet, as this book documents, it has significant flaws—including its potential to burden important research, overprotect some subjects and inadequately protect others, generate inconsistent results, and lag behind developments in how research is conducted. Invigorated by the U.S. government’s first steps toward change in over twenty years, Human Subjects Research Regulation brings together the leading thinkers in this field from ethics, law, medicine, and public policy to discuss how to make the system better. The result is a collection of novel ideas—some incremental, some radical—for the future of research oversight and human subject protection. After reviewing the history of U.S. research regulations, the contributors consider such topics as risk-based regulation; research involving vulnerable populations (including military personnel, children, and prisoners); the relationships among subjects, investigators, sponsors, and institutional review boards; privacy, especially regarding biospecimens and tissue banking; and the possibility of fundamental paradigm shifts.Less
The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation, revealed at the Nuremburg trials, and the Tuskegee syphilis study, conducted by U.S. government researchers from 1932 to 1972. This framework, combining elements of paternalism with efforts to preserve individual autonomy, has remained fundamentally unchanged for decades. Yet, as this book documents, it has significant flaws—including its potential to burden important research, overprotect some subjects and inadequately protect others, generate inconsistent results, and lag behind developments in how research is conducted. Invigorated by the U.S. government’s first steps toward change in over twenty years, Human Subjects Research Regulation brings together the leading thinkers in this field from ethics, law, medicine, and public policy to discuss how to make the system better. The result is a collection of novel ideas—some incremental, some radical—for the future of research oversight and human subject protection. After reviewing the history of U.S. research regulations, the contributors consider such topics as risk-based regulation; research involving vulnerable populations (including military personnel, children, and prisoners); the relationships among subjects, investigators, sponsors, and institutional review boards; privacy, especially regarding biospecimens and tissue banking; and the possibility of fundamental paradigm shifts.